Medical devices and IVDs: Suspensions from the ARTG

Related information

Following a review by the TGA, medical devices (including IVDs) can be suspended from the Australian Register of Therapeutic Goods. These suspensions are made by the Secretary under section 41GA of the Therapeutic Goods Act 1989.

Medical devices and IVDs can also be suspended from the ARTG if the conformity assessment certificate applying to that kind of device is suspended under section 41GF.

If a suspension occurs because of a safety concern, the TGA considers whether other actions including a recall are necessary and takes those actions when required. Any related safety alerts will appear under 'Further information'.

The reasons for a suspension are stated in the database under 'Grounds for suspension'.

The heading 'Decision status' provides updated information about a suspension, for example, a decision to extend the suspension, or information about any decision to revoke a suspension decision. It will not appear in every entry.

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Amplitude Australia Pty Ltd

Type of regulatory action:
Suspension from ARTG for a six month period under paragraph 41GA(1)(b) of the Act

Suspension start date:20/12/2017End date:19/06/2018

Grounds for suspension

ARTG 284239 was suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure

Further information

The suspension was revoked by the Secretary on 18 January 2018 as the grounds on which the kind of medical device was suspended from the Register no longer applied.

LivaNova Australia Pty Ltd

Product name/ARTG reference:3T heater-cooler device

ARTG No:194514

Type of regulatory action:
Suspended from the ARTG under section 41GA(1)(b)

Suspension start date:08/11/2017End date:08/05/2018

Grounds for suspension

There are likely grounds for cancelling the ARTG entry, in accordance with paragraphs 41GN(1)(f) and 41GN(1)(b) of the Act.

Further information

Suspension effective for 6 months

AA-Med Pty Ltd

Product name/ARTG reference:Derivo Emobolisation Device w/out tip

ARTG No:281033

Type of regulatory action:
Suspension from the ARTG under s.41GA(1)(b)

Suspension start date:03/10/2017End date:03/04/2018

Grounds for suspension

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Further information

Suspension effective for 6 months

AA-Med Pty Ltd

Product name/ARTG reference:Derivo Embolisation Device with tip

ARTG No:281030

Type of regulatory action:
Suspension from the ARTG under s.41GA(1)(b)

Suspension start date:03/10/2017End date:03/04/2018

Grounds for suspension

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Further information

Suspension effective for 6 months

Philips Electronics Australia Ltd

Product name/ARTG reference:IntelliVue MX40

ARTG No:99204

Type of regulatory action:
Suspension from ARTG for a 6 month period under paragraph 41GA(1)(a)(i) of the Act

Suspension start date:16/05/2017End date:16/11/2017

Grounds for suspension

6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious illness or serious injury if the kind of device continues to be included in the ARTG.

Further information

The suspension has been revoked in accordance with section 41 GD of the Act on 16 November 2017

Covidien/Medtronic Australasia Pty Ltd

Product name/ARTG reference:Puritan Bennett 980 Series Ventilator

ARTG No:221416

Type of regulatory action:
Suspension from ARTG for a 6 monthly period under paragraph 41GA(1)(a)(i) of the Act

Suspension start date:14/09/2017

Grounds for suspension

6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious injury or illness if the kind of device continues to be included in the ARTG.

Endotherapeutics Pty Ltd

Product name/ARTG reference:SerenoCem Granules BCG050

ARTG No:152441

Type of regulatory action:
Suspension from the ARTG under s.41GA(1)(b)

Suspension start date:31/08/2017

Grounds for suspension

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this device from the ARTG under subsection GN(1)(b).

Further information

Suspension effective for 6 months. The suspension is limited to the SerenoCem Granules BCG050 only.

Thermo Fisher Scientific Australia Pty Ltd

Product name/ARTG reference:QuickVue One-Step hCG urine test kit

ARTG No:199827

Type of regulatory action:
Suspended from the ARTG under s.41GA(1)(b)

Suspension start date:09/06/2017

Grounds for suspension

I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15.

Thermo Fisher Scientific Australia Pty Ltd

Product name/ARTG reference:QuickVue One-Step hCG urine test kit

ARTG No:254033

Type of regulatory action:
Suspended from the ARTG under s.41GA(1)(b)

Suspension start date:09/06/2017

Grounds for suspension

I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:6/05/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Device Technologies

Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)

Suspension start date:20/11/2015End date:04/11/2016

Grounds for suspension

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act

Suspension start date:23/05/2014End date:21/11/2014

Grounds for suspension

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act

Suspension start date:23/05/2014End date:21/11/2014

Grounds for suspension

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act

Suspension start date:23/05/2014End date:21/11/2014

Grounds for suspension

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference:Sizer, mammary prosthesi

ARTG No:162029

Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act

Suspension start date:23/05/2014End date:21/11/2014

Grounds for suspension

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.